FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
NIPRO SAFETOUCH LOCKTAIL SAFETY FISTULA NEEDLE
K Number: K093985
·
Decision Jan 22, 2010
Classifications
1
FEI Numbers
18
Registration Numbers
18
Same Product Code
78
Applicant Total
27
Review Days
29
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Basic Information
- Device Name
- NIPRO SAFETOUCH LOCKTAIL SAFETY FISTULA NEEDLE
- K Number
- K093985
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 876.5540
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Nipro Medical Corp.
- Date Received
- December 24, 2009
- Decision Date
- January 22, 2010
- Product Code
- FIE
- Advisory Committee
- Gastroenterology, Urology
- Review Advisory Committee
- GU
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| FIE | Needle, Fistula | FDA class 2 | Gastroenterology, Urology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (FIE), ordered by most recent decision date.
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Dimesol Disposable AV Fistula Needle Set (Non-Safety Series) and Dimesol Disposable AV Fistula Needle Set (Safety Series)
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JMS Harmony A.V. Fistula Needle Set
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ANGEL TIP SAFETY INTRAVASCULAR NEEDLE SET
FDA 510(k)
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Other Clearances by Nipro Medical Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K081210 | NIPRO SAFETOUCH HUBER INFUSTION SET | Oct 21, 2008 | Substantially Equivalent |
| K072024 | NIPRO BLOOD TUBING SET WITH TRANSDUCER PROTECTOR AND PRIMING SET, MODEL A201-A219, V801-V806, 5M9634, 5M9693 | Oct 4, 2007 | Substantially Equivalent |
| K063368 | NIPRO BIOHOLE NEEDLE | Feb 5, 2007 | Substantially Equivalent |
| K063721 | NIPRO SAFETOUCH II GAMMA | Jan 12, 2007 | Substantially Equivalent |
| K052474 | NIPRO HYPODERMIC NEEDLE | Nov 10, 2005 | Substantially Equivalent |
| K051574 | NIPRO DISPOSABLE SYRINGE WITH OR WITHOUT NEEDLE | Aug 26, 2005 | Substantially Equivalent |
| K041779 | NIPRO DISPOSABLE STOPCOCKS, MODELS 3W-RC. NCN-3, 3W-R, 3W-L | Sep 21, 2004 | Substantially Equivalent |
| K032777 | MODIFICATION TO: NIPRO SAFE TOUCH SAFETY FISTULA NEEDLE | Nov 14, 2003 | Substantially Equivalent |
| K030683 | NIPRO DISPOSABLE SYRINGES | Oct 31, 2003 | Substantially Equivalent |
| K022756 | NIPRO BIO-FLEX CATHETER | Oct 18, 2002 | Substantially Equivalent |